Evaluation of the effect of supine position and general anesthesia on the frontal and profile view of the rhinoplasty patients in Buali hospital
Design
The points needed to measure variables are marked and measured standing by patients before they receive medication. Then, while standing, while the patient's head position is adjusted using a splint, the profile photo is taken as standard by a professional photographer with a Canon power shot G11 camera from a distance of one meter.
Settings and conduct
The patient is then placed under general anesthesia by an anesthesiologist with certain medications and oral intubation is performed for the patient and the measurements are performed again and the profile is prepared by the same photographer and the same camera. In order to standardize and reduce human error in the preparation of photographs; All images are taken by a professional medical photographer with a fixed camera in an operating room and in a fixed location with the same light. A fixed place for patients and a fixed place for the photographer in the operating room are marked. All photographs are taken with the same magnification and the position of the patient's head is set in the same position by the patient. Finally, the photographs are printed on the same type of paper without any changes and edits, and the nasopharyngeal and nasolabial angles are measured and recorded using a fixed conveyor
Participants/Inclusion and exclusion criteria
Patients candidated for rhinoplasty
Minimum age of 18 years
No systemic disease
No drugs
Intervention groups
General anesthesia
Supine position
Main outcome variables
Sitting position. Supine condition before general anesthesia. Supine condition after general anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210816052200N1
Registration date:2021-11-11, 1400/08/20
Registration timing:registered_while_recruiting
Last update:2021-11-11, 1400/08/20
Update count:0
Registration date
2021-11-11, 1400/08/20
Registrant information
Name
morteza moogahi nezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3331 1107
Email address
morteza_moogahi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of supine position and general anesthesia on profile and frontal view in rhinoplasty patients in Buali hospital
Public title
Effect of supine position and GA on the nose
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidated for rhinoplasty
Minimum age of 18 years
No systemic disease
No drug usage
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Islamic Azad University of Medical Sciences
Street address
Neyestan 9 Alley, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-12-08, 1399/09/18
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.221
Health conditions studied
1
Description of health condition studied
General anesthesia and supine position
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sitting position. Supine condition before general anesthesia. Supine condition after general anesthesia
Timepoint
Before being supine, In supine position, After general anesthesia
Method of measurement
Ruler, Transporter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 52 patients are admitted to the study after considering the inclusion and exclusion criteria. The points needed to measure variables are marked and measured standing by patients before they receive medication. Then, while standing, while the patient's head position is adjusted using a splint, the profile photo is taken as standard by a professional photographer with a Canon power shot G11 camera from a distance of one meter. The patient is then supine in the same room, with the bed parallel to the ground, re-measured, and profile photos are taken again by the same photographer, with the same camera and from a distance of one meter. The patient is then placed under general anesthesia by an anesthesiologist with certain medications and oral intubation is performed for the patient and the measurements are performed again and a profile is prepared by the same photographer and the same camera.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Buali hospital
Full name of responsible person
Dr. Hossein Tafazzoli Shadpour
Street address
Neyestan 9 Alley, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
drhostaf@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Hossein Tafazzoli Shadpour
Street address
Neyestan 9 Alley, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
drhostaf@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Hossein Tafazzoli Shadpour
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
Neyestan 9 Alley, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
drhostaf@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Hossein Tafazzoli Shadpour
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
Neyestan 9 Alley, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
drhostaf@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Morteza Moogahi Nezhad
Position
Resident of oral and maxillofacial surgery
Latest degree
Medical doctor
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
Neyestan 9 Alley, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
morteza_moogahi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only main outcome
When the data will become available and for how long
It will be published before autumn next year
To whom data/document is available
Only researchers in university
Under which criteria data/document could be used
To do more studies
From where data/document is obtainable
Dental school of Tehran Islamic Azad university library
What processes are involved for a request to access data/document